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COMPLETED
NCT07549581
PHASE1

A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive episode associated with bipolar I or II disorder or major depressive disorder (MDD).

Official title: A Phase 1b, Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of SEP-380135 in Adults With Schizophrenia or With a Major Depressive Episode Associated With Bipolar I or II Disorder or Major Depressive Disorder

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2024-11-07

Completion Date

2025-09-12

Last Updated

2026-04-24

Healthy Volunteers

No

Interventions

DRUG

SEP-380135

oral capsule.

DRUG

Placebo

Placebo capsule.

Locations (1)

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States